BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1233543 · Received November 10, 2008

    Report

    Report Number
    1213643-2008-00486
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 1, 2007
    Report Date
    October 15, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    k963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A F/U REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL, OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PER MAUDE EVENT REPORT AND INFO OBTAINED FROM SPEAKING WITH PT ON 10/16/2008: IN 2005, PT UNDERWENT RIGHT SIDE ON ABDOMEN HERNIA REPAIR WITH MESH. PT EXPERIENCED PAIN AND WENT BACK TO SEE THE DR SEVERAL TIMES. PT REC'D "NERVE BLOCKS" AND WAS REFERRED TO THE PAIN CLINIC. THE PT HAS A TENS UNIT CURRENTLY FOR TREATMENT OF HER PAIN. PT REPORTS SHE RECEIVES NERVE BLOCKS EVERY OTHER MO, AND THE RECOMMENDATION FROM THE PAIN CLINIC PHYSICIAN IS TO HAVE A NEUROSTIMULATOR IMPLANTED. IN 2007, PT UNDERWENT PARTIAL MESH EXPLANT, WHERE PT REPORTS IT WAS NOTED THAT THE MESH HAD MIGRATED TO HER LIVER AND BALLED UP. IN 2007-- RIGHT OOPHERECTOMY AND ANOTHER HERNIA SURGERY DONE IN THE FRONT ABDOMEN, ACCORDING TO PT. ALONG WITH PAIN, THE PT REPORTS BLOATING, LEG NUMBNESS, AND THE SENSATION OF SOMETHING GRINDING INTO HER RIB AND HIP BONE. PAIN MEDICATIONS CURRENTLY PRESCRIBED ARE MORPHINE AND DARVOCET. SHE IS ALSO PRESCRIBED CYMBALTA FOR THE TREATMENT OF DEPRESSION SHE IS EXPERIENCING DUE TO THE MESH. PT REPORTS SHE IS IN THE PROCESS OF LOOKING FOR A SURGEON TO EXPLANT THE REMAINING MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention PAIN CLINIC TREATMENT FOR CRONIC PAIN ISSUES